The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox 2 Voice Prosthesis System.
| Device ID | K971244 |
| 510k Number | K971244 |
| Device Name: | PROVOX 2 VOICE PROSTHESIS SYSTEM |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Contact | Eddy Aberg |
| Correspondent | Eddy Aberg ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-03 |
| Decision Date | 1997-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791010071 | K971244 | 000 |
| 07331791010064 | K971244 | 000 |
| 07331791010057 | K971244 | 000 |
| 07331791010040 | K971244 | 000 |
| 07331791010033 | K971244 | 000 |
| 07331791010026 | K971244 | 000 |